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In the statistical theory of design of experiments, randomization involves randomly allocating the experimental units across the treatment groups. For example, if an experiment compares a new drug against a standard drug, then the patients should be allocated to either the new drug or to the standard drug control using randomization.

Randomized experimentation is not haphazard. Randomization reduces bias by equalising other factors that have not been explicitly accounted for in the experimental design (according to the law of large numbers). Randomization also produces ignorable designs, which are valuable in model-based statistical inference, especially Bayesian or likelihood-based. In the design of experiments, the simplest design for comparing treatments is the "completely randomized design". Some "restriction on randomization" can occur with blocking and experiments that have hard-to-change factors; additional restrictions on randomization can occur when a full randomization is infeasible or when it is desirable to reduce the variance of estimators of selected effects.

Randomization of treatment in clinical trials pose ethical problems. In some cases, randomization reduces the therapeutic options for both physician and patient, and so randomization requires clinical equipoise regarding the treatments.

Randomized experiments were institutionalized in psychology and education in the late eighteen-hundreds, following the invention of randomized experiments by C. S. Peirce.[6][7][8][9] Outside of psychology and education, randomized experiments were popularized by R.A. Fisher in his book Statistical Methods for Research Workers, which also introduced additional principles of experimental design.

The Rubin Causal Model provides a common way to describe a randomized experiment. While the Rubin Causal Model provides a framework for defining the causal parameters (i.e., the effects of a randomized treatment on an outcome), the analysis of experiments can take a number of forms. Most commonly, randomized experiments are analyzed using ANOVA, Student's t-test, Regression analysis, or a similar statistical test.